Quality Engineer II (Hybrid)

BD • Franklin Lakes, NJ

308d

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. As directed by the Quality Manager, the Quality Engineer II is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Requirements

• Bachelor's Degree.
• A minimum of 2 years confirmed experience or a combination of equivalent education and shown experience.
• Moderate knowledge of applicable regulatory, Corporate and / or Unit requirements.
• Training in statistics.
• Class II / III medical device experience (preferred).
• Knowledge of design control principles (preferred).
• Ability to provide support to internal / external audits.

Responsibilities

• Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools.
• Develops solutions to routine problems of moderate scope.
• Follows company procedures and makes basic procedural updates.
• Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements.
• Communicates across functions / departments for assigned areas of responsibility.
• Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
• Provides audit support (preparation, closure, etc. activities).
• Design Control: Design Input, Design Output, Design Verification plans, protocols, and reports, Design Reviews, Design Validation, Design History File support.
• Change Control Assessment of Change Request (ACR) Responses.
• Risk Management Process Validations.
• Identification of CTQ's.
• Unit Quality Independent Reviewer During Design Reviews.
• Handling of deviations and non-conformances.
• Test method validations.
• Supplier qualification.
• Software validations.
• Post Market Surveillance.
• Situation Analysis.
• CAPA - Root cause investigation and implementation of corrective / preventive actions.
• Accurate Use of Statistics (Sampling Plans).
• Advise on Regulations.
• Liaise with Manufacturing Plants.
• Provide functional support to multi-functional teams.
• Internal and external audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree